Trust rewarded with pain

In meningitis outbreak, government, business thwart patient safety

Oct. 14, 2012

A Minnesota Department of Health lab technician packages the cerebrospinal fluid of three confirmed meningitis cases in that state to send to the CDC for testing. The number of confirmed cases is close to 200 nationally. / Associated Press

This nation runs on trust. And when people and institutions violate that trust, it is essential they do everything possible to regain our confidence and belief.

Where in this national outbreak of fungal meningitis, in which Tennessee is ground zero, do we see that urgency?

Patients have lost confidence in esteemed medical institutions.

Federal and state governments have failed at their responsibility to provide regulatory oversight.

It has an insidious uncertainty, this disease. While the number of patients confirmed sick is near 200 nationally, about 14,000 people received injections of the contaminated drug. Many of them may develop meningitis; many may not.

And in a most cynical way, we see, through the use of compounded drugs, how some people have devalued the cost of human life.

It has taken two weeks for officials with the U.S. Food and Drug Administration, along with health officials in Tennessee, Massachusetts and other states, to begin to speak with one voice, and with a sense of urgency. The FDA says conflicting court rulings have hindered its ability to regulate centers such as New England Compounding. Why are we only now hearing this?

Even though Massachusetts law requires that every dose of compounded drug has an individual prescription, New England Compounding has long operated without those prescriptions. Why wasn’t the company cited sooner?

Tennessee received the greatest number of doses of the latest contaminated steroid medicine. State health officials have given assurances that they are doing all they can to address the problem. And yet, as of Friday, the state still listed New England Compounding as having an active, viable license. The state Board of Pharmacy could remedy this now by calling a meeting; instead, it is scheduled to convene in mid-November.

Apparently, our worst fears are not enough to rouse bureaucrats from their complacency.

If health officials think that they can “manage” this crisis because all the doses have come from one site and have since been recalled, they really should think again. As a USA Today report found, centers such as New England Compounding have been tied to more than two dozen fatal infections and overdoses since 2001. This information was not kept in hidden files but in state and federal records, academic journals and industry reports.

So, let’s ask again: Why only now? Perhaps it has to do with the business of pain management and pharmaceuticals.

The steroid that has caused this outbreak was a cheaper compounded version of a drug whose price skyrocketed after generic supplies started to run out. Many, but not all, clinics, hospitals and pain centers went for the cheaper version.

Certainly, these practices want to ensure they have ample supply of drugs that their patients need. Some also want to balance their books; some want to turn a profit. When a vial of the drug went from $3 to $40, it was a problem.

But nowhere near the problem that comes from infecting people with a potentially fatal fungus. The fact that drugs from compounding pharmacies are not as well-regulated as brand-name drugs is well-known to health professionals. Those who will buy only brand-name drugs know that it is more important to absorb the cost if it protects their patients.

Before this terrible tragedy goes much further, we know this: Lawmakers in Congress need to act, and soon, to clarify FDA and states’ authority over these specialized pharmacies. Pain management providers should explain whether they knowingly took a risk by purchasing compounded drugs; and Tennessee health officials should close the door on the New England company whose handiwork has led to many deaths.

These patients trusted their care providers to ease their pain — not remove any chance of it.